A Trial of Restrictive Versus Traditional Blood Transfusion Practices in Burn Patients

American Burn Association

Status: Completed

Conditions: Burn Injury

Treatments: Other: Restrictive transfusion threshold; Other: Liberal transfusion threshold

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT01079247

ABA-MCTG-0001

Details and patient eligibility

About

The purpose of this study is to find out if burn injured patients do better receiving fewer blood transfusions than what is traditionally given. We traditionally provide blood transfusions to maintain a hemoglobin level, which is an indicator of the level of red blood cells that carry oxygen in your body, to above 10 g/dl (g/dl stands for grams per deciliter and is the standard measurement used to indicate the level of red blood cells in your blood). However, a preliminary study indicated that maintaining the hemoglobin level to above 7-8 g/dl with less blood transfusion, as compared to a hemoglobin level of 10 g/dl and above, would reduce the occurrence of blood infection, duration on the respirator and length of hospital stay, yet would achieve similar survival in both groups.

Enrollment: 347 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• >20% TBSA burn with anticipated operation need on admission as determined by attending physician
• age >18 years
• Admission within 96 hours of injury

Exclusion criteria

• <18 years of age
• pregnancy
• inability or unwillingness to receive blood products
• history of chronic anemia (hemoglobin <9.0 g/dL one month prior to enrollment)
• preexisting need for hemodialysis
• brain death or imminent brain death
• non-survivable burn as determined by the attending burn surgeon
• angina or acute myocardial infarction
• preexisting hematologic disease
• Length of hospital stay anticipated to be < 2 weeks
• Transfusion administered at outside hospital before admit

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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347 participants in 2 patient groups

Liberal

Active Comparator group

Description:

Maintain hemoglobin at 10-11 g/dL

Treatment:

Other: Liberal transfusion threshold

Restrictive

Active Comparator group

Description:

Maintain hemoglobin at 7-8 g/dL

Treatment:

Other: Restrictive transfusion threshold